A Bioequivalence study on the innovator and a generic amoxicillin trihydrate 500mg capsules in healthy volunteers

niversity of Colombo0 个研究点开始时间: 待定最近更新: 2024年8月20日

研究概览

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•1. Healthy volunteer males and females of 18-55 years of age.
•2. Weight within the normal range according to accepted normal values for the Body Mass Index between 18-25 kg/m2
•3. Stable health screening for medical and medical histories, physical examination, vital signs, ECG, Renal Function Test, Liver Function Test, Blood Glucose, Complete Blood Count and urine pregnancy test for females.
•4. Preferably be non-smokers and without a history of alcohol or drug abuse.

•1. History of allergic reactions to the selected drug and or its constituents
•2. History or concurrent symptoms of allergy, cardiovascular, liver, kidney, gastrointestinal, hematological disorders and/or any disease that may affect the bioavailability of the drug
•3. Regular alcohol consumption (more than 1 time/week) or drug abuse
•4. Smokers or ex-smoker less than 30 days
•5. Use of any drugs within 14 days prior to administration of the first study drug and willing to take them throughout the study period
•6. Use of food supplements taken as capsules or tablets or neutraceuticals, vitamins, minerals, herbal remedies, and/or contraceptives hormonal within 14 days before first study drug administration and willing to taking them throughout the study period
•7. History of gastrointestinal disease
•8. Already participated in another clinical study within last 30 days
•9. Pregnant (positive pregnancy test) or breast feeding
•10. Blood donation within last 90 days

发起方

niversity of Colombo